FDA delays PDUFA date for Rocket’s rare white blood cell disorder gene therapy

The FDA’s de­ci­sion on Rock­et Phar­ma­ceu­ti­cals’ au­tol­o­gous gene ther­a­py for a rare white blood cell dis­or­der has been pushed back by three months to June 30 to give the agency more time to re­view its chem­istry man­u­fac­tur­ing and con­trols.

The com­pa­ny’s stock $RCKT was down 4% on Tues­day af­ter the mar­ket opened. The ex­per­i­men­tal ther­a­py, RP-L201, pre­vi­ous­ly had a PDU­FA date of March 31 for leuko­cyte ad­he­sion de­fi­cien­cy-I (LAD-I).

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